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HuHuangLianzonggan Capsule in...

HuHuangLianzonggan Capsule in Subjects With Nonalcoholic Steatohepatitis: a Phase 2 tRial(HHL-HEPAR)

Last Updated: 2024-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-21

Study Completion Date

2024-12-31

Brief Summary

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This study will evaluate the efficacy and safety and the best effective dose of HuHuangLianzonggan capsule in subjects with nonalcoholic steatohepatitis.

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Detailed Description

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Conditions

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NASH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group

HuHuangLianzonggan capsule, 4 pills, take orally after meals, 2 times a day

Group Type EXPERIMENTAL

HuHuangLianzonggan capsule

Intervention Type DRUG

HuHuangLianzonggan capsule, 4 pills(120 mg per pill), take orally after meals, 2 times a day for 12weeks

Placebo group

HuHuangLianzonggan capsule placebo, 4 pills, take orally after meals, 2 times a day

Group Type PLACEBO_COMPARATOR

HuHuangLianzonggan capsule placebo

Intervention Type DRUG

HuHuangLianzonggan capsule placebo, 4 pills(120 mg per pill), take orally after meals, 2 times a day for 12weeks

Interventions

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HuHuangLianzonggan capsule

HuHuangLianzonggan capsule, 4 pills(120 mg per pill), take orally after meals, 2 times a day for 12weeks

Intervention Type DRUG

HuHuangLianzonggan capsule placebo

HuHuangLianzonggan capsule placebo, 4 pills(120 mg per pill), take orally after meals, 2 times a day for 12weeks

Intervention Type DRUG

Other Intervention Names

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Experimental group Placebo group

Eligibility Criteria

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Inclusion Criteria

1. Males and females between 18-75 years of age inclusive(including boundary values).
2. Must have had a liver biopsy proven NASH within 6 months or in screening test. The following two requirements must be met at the same time: ① a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components: Steatosis≥1, Lobular inflammation≥1, Ballooning degeneration≥1;② fibrosis stage 1 to 3.
3. Must have confirmation of ≥ 8% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.
4. No alcohol consumption or history of excessive alcohol consumption: less than 210 g of ethanol per week for men and 140 g for women in the past 12 months.
5. Patients who are taking chronic drugs(including but not limited to antihypertensive drugs, antiatherogenic drugs, oral hypoglycemic drugs, insulin) need to have a steady dose for at least 3 months before liver biopsy.
6. Weight was stable(the change is no more than 5%) during the 6 months prior to Screening.
7. No attempt to change lifestyle (diet and/or exercise) during the 3 months prior to Screening.
8. Ability to understand the requirements of the study and willingness to provide written informed consent.
9. Have no pregnancy program and take effective contraceptive measures voluntarily.
10. Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment.

Exclusion Criteria

1. Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) administered for at least 2 weeks within 12 months prior to qualifying liver biopsy (e.g. valproic acid, tamoxifen, methotrexate, amiodarone, oral corticosteroids, \>5 mg/day of prednisone equivalent \[one short (\<2 weeks) course of oral corticosteroids, more than 3 months before the liver biopsy is allowed\], or oestrogens \[at doses greater than those used for contraception or hormone replacement\]).
2. Documented causes of fatty liver disease other than NASH including, but not restricted to: HCV-associated fatty liver (genotype 3), hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition, abetalipoproteinemia, lipoatrophy , Coeliac disease, Primary sclerosing cholangitis, Alpha-1-antitrypsin deficiency, Drug-induced liver disease.
3. Model for End-stage Liver Disease (MELD) score \>12.
4. Histologically documented liver cirrhosis (fibrosis stage F4), history or current diagnosis of hepatocellular carcinoma HCC.
5. History of or planned liver transplant.
6. Viral hepatitis：Positive hepatitis A antibody，Positive hepatitis D antibody，Positive hepatitis E antibody，Positive hepatitis B surface antigen (HBsAg) ，Positive hepatitis C antibody.
7. Abnormal liver function as defined by Screening central laboratory evaluation of any of the following: ALT or AST \>5 × ULN; Alkaline phosphatase (ALP) \>2 × ULN; albumin below the lower limit of the normal range; total bilirubin level \>1.5 × ULN (patients with a documented history of Gilbert's syndrome can be enrolled if the direct bilirubin is within normal reference range).
8. In patients who are not anticoagulated, INR ≥ 1.3 times ULN or other evidence of impaired coagulation.
9. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value \<30 mL/min/1.73 m2.
10. Patient currently receiving any approved treatment for NASH.
11. HbA1c ≥9% or fasting blood-glucose\>13.9 mmol/L at Screening.
12. Diabetes mellitus other than type 2 (e.g. type 1, diabetes caused by drugs or chemicals, and immune-mediated diabetes).
13. Those who are underweight, of normal weight, or severely obese, i.e BMI\<23 kg/m2 or BMI≥40 kg/m2.
14. Bariatric surgery or tumor surgery are not allowed within 5 years of the qualifying liver biopsy.
15. Uncontrolled hypertension (values ≥160/100 mm Hg) or hypotension（values \<80/50 mmHg）.
16. Acute vascular events including ACS, stroke, peripheral vascular disease worsened, or any vascular/cardiac surgery within the 6 months prior to Screening.
17. Concomitant mental illness and poor condition control, which affects the signing of informed consent or presentation of adverse events.
18. Do not have a liver biopsy within the 6 months prior to Screening and refuse to take liver biopsy at Screening.
19. Allergic constitution, or allergic to the test drug or its ingredients.
20. Women who are pregnant or lactating.
21. Participate in clinical trials of other drugs within 3 months before screening.
22. The researchers did not consider it appropriate to participate in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers